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Device Explorer · FDA GUDID · GMDN 37068

Pulmonary function valve

A non-sterile, dedicated valve intended to be used with a parent device for the measurement/analysis of a patient's pulmonary function. It is typically used to control inspired/expired gas directional flow and assist in the inhalation and distribution of test

US‑registered devices108in commercial distribution
Companies1labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Hans Rudolph, Inc.108100%

Top labelers

CompanyDevicesShare
Hans Rudolph, Inc.108100%

Company = labeler of record on GUDID. 1 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

7910 MASK6450 RV2 MASK7450 RV2 MASK6450 DV2 MASKCR1738 ONE WAY VALVE1230 1Way Valve

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
BYXTubing, Pressure And Accessories279
KGBMask, Oxygen, Non-Rebreathing272
JAYSupport, Breathing Tube9
CBPValve, Non-Rebreathing6
JAXPneumotachometer1

GMDN & GCC registration

  • GMDN code 37068 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many pulmonary function valve products are registered in the US?

108 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pulmonary function valve", from 1 companies. The largest labeler is Hans Rudolph, Inc. with 100% of records.

Which FDA product codes apply?

BYX (Tubing, Pressure And Accessories), KGB (Mask, Oxygen, Non-Rebreathing), JAY (Support, Breathing Tube), CBP (Valve, Non-Rebreathing)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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